Identifying and Reporting Unanticipated Problems

In this video, Dr. Michael Carome from the Office for Human Research Protections (OHRP) discusses the criteria for determining if an experience, incident, or outcome is an unanticipated problem involving risk to subjects or others, as described in the HHS regulations at 45 CFR part 46. He discusses the differences between adverse events and unanticipated problems and appropriate responses for investigators, IRBs, and institutions when encountering an unanticipated problem. He also discusses prompt reporting requirements and the difference between external and internal unanticipated problems, what to do in the case of multi-center research, and what information that should be reported to OHRP.